286
Participants
Start Date
October 24, 2022
Primary Completion Date
June 30, 2026
Study Completion Date
September 30, 2026
NSS-2 BRIDGE
"NBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.~Once the device is placed, subjects will be asked to perform a pinch test throughout the duration of their time wearing the device. To perform the pinch test subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose."
Sham NSS-2 BRIDGE
Sham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.
RECRUITING
University of Pittsburgh Medical Center - Magee-Womens Hospital, Pittsburgh
RECRUITING
UPMC Montefiore Hospital, Pittsburgh
RECRUITING
University of Pittsburgh Medical Center - Shadyside Hospital, Pittsburgh
RECRUITING
University of Pittsburgh Medical Center - Passavant Hospital, Pittsburgh
Collaborators (1)
Masimo Corporation
INDUSTRY
National Institute on Drug Abuse (NIDA)
NIH
Jacques E. Chelly
OTHER